FDA.reportPublic FDA data

FD&C BLUE NO. 1

Substance profile for UNII H3R47K3TBD, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#

UNII
H3R47K3TBD
Preferred term
FD&C BLUE NO. 1
Registry number
3844-45-9
Ingredient type
INGREDIENT SUBSTANCE

Chemical And Database Identifiers#

RxCUI
1310605
PubChem
0
NCIt
C71674
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
RxNorm1310605mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1310605
NCI ThesaurusC71674ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C71674
FDA Substance Registration SystemH3R47K3TBDprecision.fda.gov/uniisearch/srs/unii/H3R47K3TBD

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
BenePatch (69418-002)11
These highlights do not include all the information needed to use KEFLEX ® safely and effectively. See full prescribing information for KEFLEX ® KEFLEX ® (cephalexin) capsules, for oral use Initial U.S. Approval: 197110
Terazosin Capsules, USP10
Terazosin Hydrochloride Capsules9
Propranolol Hydrochloride Tablets, USP1001
These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 19951000
These highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 194320
Pleasure Balm9
MECLIZINE HYDROCHLORIDE TABLETS USP R x only13
Fenoprofen Calcium Capsules, USP 200 mg and 400 mg1000
These highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 194313
Pleasure Balm10
NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 21311002
ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only1001
Unknown Title1000
Imipramine Hydrochloride Tablets USP 10 mg, 25 mg and 50 mg1000
These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. AMLODIPINE besylate and BENAZEPRIL hydrochloride capsules for oral use Initial U.S. Approval: 19951000
These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 19951001
CEPHALEXIN CAPSULES, USP8
These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral Use Initial U.S. Approval: 198715
These highlights do not include all the information needed to use PRASTERA ® safely and effectively. See full prescribing information for PRASTERA ® . PRASTERA ® prasterone oral softgels 200mg are for oral use only. Initial U.S. Approval13
SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate8
Sotalol Hydrochloride Tablets USP18
Product Information Zonisamide Capsules Rx Only1000
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only13
These highlights do not include all the information needed to use glimepiride information safely and effectively. See full prescribing information for glimepiride. Glimepiride Tablets USP Initial U.S. Approval: 199510
Zonisamide Capsules11
GABAPENTIN CAPSULES, USP 40-9155 Revised — September 2011 Rx only27
Diphendydramine Hydrochloride Capsules8
These highlights do not include all the information needed to use Dicyclomine Hydrochloride safely and effectively. See full prescribing information for Dicyclomine Hydrochloride. Dicyclomine Hydrochloride Capsules, for oral use. Dicyclomine Hydrochloride Tablets, for oral use. Initial U.S. Approval: 19509
40-9165 Revised-October 2011 Rx only14
Methergine1000
Lisinopril and Hydrochlorothiazide13
Propranolol Hydrochloride Tablets, USP1000
LISINOPRIL and HYDROCHLOROTHIAZIDE TABLETS USP Rx only1000
Verapamil Hydrochloride Sustained-Release Capsules1000
Adderall ® CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets)1000
80b7007e-be26-4388-8d62-9541baf75c6b1000
These highlights do not include all the information needed to use warfarin sodium tablets USP safely and effectively. See full prescribing information for warfarin sodium. Initial U.S. Approval: 19541000
CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only9
Gabapentin Capsules, USP8
Levothyroxine Sodium Tablets, USP9
Veti-Foam Hand Soap9
Indomethacin Extended – Release Capsules, USP 75 mg3231
Medrox-Rx8
These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19879
Appformin9
Strazepam17
Theracodophen-Low-9013
Appbutamone-D12
Fluoxetine 10 mg These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19879
Fluoxetine 10 mg These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19878
AMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg 3107 3109 2267 2268 4150 4155 Rx only10
ADVENTURE MEDICAL KITS 1-2 PERSON [1.0] FIRST AID KIT10
ADVENTURE MEDICAL KITS 1-4 PERSON [2.0] FIRST AID KIT9
Clindamycin Hydrochloride 150 mg452
Virx Hand Sanitizing Spray with Aloe Vera117
FLUOXETINE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3979
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3978
CLONAZEPAM TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3972
DIAZEPAM TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3967
PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3956
ZALEPLON CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3951
TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
NORTRIPTYLINE HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3923
NITROFURANTOIN (MACROCRYSTALS) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3922
INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3862
PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3857
VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3842
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3834
HYDROXYZINE PAMOATE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3821
DOXYCYCLINE HYCLATE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3749
MEXILETINE HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3749
NITROFURANTOIN MACROCRYSTALS CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3740
DOXEPIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3724
COUMADIN (WARFARIN SODIUM) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3703
PROPRANOLOL HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3699
PROPRANOLOL HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3697
PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3688
MORPHINE SULFATE EXTENDED-RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3678
DICLOXACILLIN SODIUM CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3674
ESTRADIOL TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3657
FLURBIPROFEN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3626
AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3623
DOXEPIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3616
KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3612
ZONISAMIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3563
TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3561
NORTRIPTYLINE HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3554
GABAPENTIN (GABAPENTIN ) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3480
CLONAZEPAM TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3476
NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3473
CLINDAMYCIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3471
KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3413
OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3369
GLYBURIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3366
ZALEPLON CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3316
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3315
GABAPENTIN CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3306
SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3257
HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3232
OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3165
AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3124
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3108
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3024
CLINDAMYCIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2089
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM) CAPSULE [ABBVIE INC.]1547
DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
BIAXIN (CLARITHROMYCIN) TABLET, FILM COATED BIAXIN (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE BIAXIN (CLARITHROMYCIN) GRANULE, FOR SUSPENSION [ABBVIE INC.]1531
SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [ABBVIE INC.]1492
SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PD-RX PHARMACEUTICALS, INC.]1401
RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1004
AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1002
DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
ERGOCALCIFEROL CAPSULE [BRYANT RANCH PREPACK]1002
ESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
ESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
FLURBIPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1002

Inactive Ingredient Database#

Browse recovered IID releases and source provenance.

Current IID rows for UNII H3R47K3TBD page 1 of 1 · 37 matching rows.

Ingredient, UNII, CAS table
IngredientUNIICASDosage formRoutePotencyMaximum daily exposure
FD&C BLUE NO. 1H3R47K3TBD3844459CONCENTRATEBUCCALNA
FD&C BLUE NO. 1H3R47K3TBD3844459MOUTHWASHBUCCALNA
FD&C BLUE NO. 1H3R47K3TBD3844459PASTEDENTALNA
FD&C BLUE NO. 1H3R47K3TBD3844459PASTE, DENTIFRICEDENTALNA
FD&C BLUE NO. 1H3R47K3TBD3844459SOLUTIONDENTALNA
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULEORAL26.3 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, COATED PELLETSORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, COATED, EXTENDED RELEASEORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, DELAYED RELEASEORAL2 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, DELAYED RELEASE PELLETSORAL0.01 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, EXTENDED RELEASEORAL1 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CAPSULE, LIQUID FILLEDORAL0.08 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CONCENTRATEORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459ELIXIRORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459FILM, SOLUBLEORAL0.04 mg
FD&C BLUE NO. 1H3R47K3TBD3844459LIQUIDORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459POWDER, FOR SOLUTIONORAL0.04 mg/5ml
FD&C BLUE NO. 1H3R47K3TBD3844459POWDER, FOR SUSPENSIONORAL1 mg/5ml
FD&C BLUE NO. 1H3R47K3TBD3844459SOLUTIONORAL1.13 mg/15ml
FD&C BLUE NO. 1H3R47K3TBD3844459SUSPENSIONORAL1 mg
FD&C BLUE NO. 1H3R47K3TBD3844459SYRUPORAL0.05 mg/5ml
FD&C BLUE NO. 1H3R47K3TBD3844459TABLETORAL27.53 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLET, COATEDORAL0.52 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLET, DELAYED RELEASEORAL0.01 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLET, EXTENDED RELEASEORAL4 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLET, FILM COATEDORAL0.16 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLET, SUGAR COATEDORALNA
FD&C BLUE NO. 1H3R47K3TBD3844459SOLUTIONRECTAL0.01 %w/v
FD&C BLUE NO. 1H3R47K3TBD3844459FILMSUBLINGUAL0.07 mg
FD&C BLUE NO. 1H3R47K3TBD3844459TABLETSUBLINGUAL0.03 mg
FD&C BLUE NO. 1H3R47K3TBD3844459CREAMTOPICAL0.01 %w/w
FD&C BLUE NO. 1H3R47K3TBD3844459LIQUIDTOPICALNA
FD&C BLUE NO. 1H3R47K3TBD3844459LOTIONTOPICALNA
FD&C BLUE NO. 1H3R47K3TBD3844459SHAMPOOTOPICAL0.75 %w/w
FD&C BLUE NO. 1H3R47K3TBD3844459SOAPTOPICAL0.01 %w/w
FD&C BLUE NO. 1H3R47K3TBD3844459SOLUTIONTOPICAL0.01 %w/w
FD&C BLUE NO. 1H3R47K3TBD3844459DOUCHEVAGINALNA